BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SOFAMOR DANEK

    MDR report key: 3074656 · Received April 18, 2013

    Report

    Report Number
    MW5029882
    Event Type
    Injury
    Date Received
    April 18, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    JDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD AN OPEN REDUCTION, INTERNAL FIXATION OF LEFT OLECRANON ON (B)(6) 2013. THE PT HAD TO RETURN TO SURGERY FOR A REVISION OF OPEN REDUCTION, INTERNAL FIXATION OF LEFT OLECRANON ON (B)(6) 2013. THE CABLE USED FOR THE INITIAL REPAIR BECAME DISASSOCIATED AT THE CRIMPING DEVICE. THE RETAINING MECHANISM SLIPS THROUGH THE CRIMP EYELET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167048 MEDTRONIC SOFAMOR DANEK ATLAS SINGLE CABLE W/INTEGRAL CRIMP JDQ MEDTRONIC SOFAMOR DANEK 826-213 0203630W

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization USED IN CONJUNCTION W/ ACUMED TENSION BAND KIT